A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation

This study has been completed.

Sponsor:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT01279538

First Posted: January 19, 2011

Last Update Posted: February 10, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject is a recipient of a de novo kidney transplant from a living or deceased donor

Prior to randomization, the subject has a post-transplant serum creatinine value that is at least 30% decreased from the pre-transplant value and requires no dialysis

Female subject of child bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment or upon hospitalization and must agree to maintain effective birth control during the study

All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agrees to no sperm donation until the end of the study, or for 90 days after the last dose of study drug, whichever is longer

Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions

Subject has previously received or is receiving an organ transplant other than a kidney

Recipient has a positive T or B cell crossmatch

Subject has ABO blood type incompatibility with their donor

Subject has received intravenous immunoglobulin (IVIG) therapy in the 3 months prior to first dose of study drug

Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)

Subject had a thromboembolic event (e.g., myocardial infarction, cerebrovascular event, pulmonary embolus, deep vein thrombosis, peripheral arterial thromboembolic event) in the past 5 years or if the subject is on specific therapy for prophylaxis or treatment of such an event. Low dose aspirin (81 mg) therapy is not considered exclusionary. NOTE: A one-time event of arterio-venous (AV) fistula dialysis access thrombosis is not exclusionary. Subjects with recurrent AV fistula thrombosis or those on systemic medications to prevent reoccurrence are excluded

Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully

Subject has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives

Subject is concurrently participating in another drug study or has received an investigational drug up to 8 weeks (depending on medication) prior to transplant

Subject has previously received ASKP1240 or participated in a study involving ASKP1240

Subject has abnormal chest x-ray indicative of acute or chronic lung disease on a prior examination within 3 months prior to randomization

Subject has abnormal electrocardiogram (ECG) considered as clinically significant on a prior examination within 3 months prior to randomization

Subject has uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, any clinically significant cardiac disease, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements

Subject has received live or live attenuated virus vaccinations within the last 30 days prior to first dose of study drug

Subject has a clinical condition which would not allow safe conduct and completion of the study

Subject is pregnant or lactating

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279538